Open Trial of an ACT Skills Group and Mobile App for Worry

June 5, 2020 updated by: Michael Twohig, Ph.D., Utah State University

An ACT Skills Group and Mobile App for Worry

This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD.

Study hypotheses are:

  1. Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
  2. Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
  3. Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants and power:

Each group will include 6-12 participants. The target sample size is 36 participants, which would provide good power (0.90) to detect a medium effect size in a repeated-measures ANOVA with three time points and requires running at least 3 groups.

All clinics on the Utah State University campus will be asked to refer their waitlist clients to the group, if appropriate (e.g., client presented with significant worry). Local private practitioners in the Cache Valley, Utah area may also be notified about the option to refer their waitlist clients to the group. Fliers will be posted on the Utah State University campus and in the local community and distributed to providers to provide more information on the study. Fliers will direct interested individuals to contact the researchers. The study will also be listed on the Utah State University Contextual Behavioral Science Lab website with a link to the pre-screening.

Procedures:

Individuals who contact the researchers expressing interest will be sent more information on study procedures and asked to complete a brief online pre-screening specific to this study.

If potential participants are likely to be eligible based on the online pre-screening, they will be asked to schedule an initial assessment. They will be asked to review a consent form and given an opportunity to ask any questions. Those who decide to participate and sign the consent form will be administered the MINI International Neuropsychiatric Interview to check eligibility (i.e., GAD diagnosis, no serious mental illness), then asked to complete a series of self-report measures hosted on Qualtrics on an iPad to establish a baseline.

The group intervention will begin when the groups are filled. There will be no cost or compensation for participating in the groups. They will be facilitated by two doctoral students with training in ACT. Participants will be informed about and trained in using the ACT Daily mobile app at the first group and reminded about how to use it at each weekly group. Reminders about using the app will also be sent weekly through email or text to participants in the follow-up period.

Participants will be asked to complete a credibility questionnaire on paper at the end of the first session. They will be asked to complete an online post-treatment survey after the group sessions conclude, and a final online follow-up survey one month later.

Intervention:

The group therapy intervention consists of six weekly sessions of acceptance and commitment therapy (ACT). Each session will be two hours long. The intervention was developed based on established ACT protocols and adapted to fit the group format and generalized anxiety. The intervention uses metaphors, experiential exercises, and discussion to target the core elements of ACT: acceptance, defusion, present moment awareness, self-as-context, values, and committed action. Groups will be closed (i.e. new group members will not be added as sessions progress). Sessions will be video recorded for the purposes of training and supervision and to allow for a review of treatment fidelity.

The ACT Daily mobile app is hosted on Qualtrics and teaches a variety of ACT skills targeting acceptance, defusion, present moment awareness, values, and committed action. Users will answer some brief questions regarding their current symptoms and psychological flexibility and then be recommended a tailored skill relevant to the psychological flexibility process that they report struggling with the most in the moment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Logan, Utah, United States, 84322
        • Utah State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Seeking treatment for worry
  2. Fluent in English
  3. At least 18 years old
  4. Have no serious mental illness
  5. Not currently receiving other treatment
  6. Meeting diagnostic criteria for generalized anxiety disorder

Exclusion criteria mirror inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT groups and mobile app
Participants will receive six two-hour weekly sessions of acceptance and commitment therapy (ACT) in a group format. They will also access the ACT Daily mobile app, which helps participants practice ACT skills in the moment, for the duration of the study (10-14 weeks depending on when the participant completes the baseline assessment.) Sessions use metaphors, experiential exercises, and discussion to target core ACT skills: acceptance, defusion, present-moment awareness, self-as-context, values, and committed action. The mobile app includes metaphors and experiential exercises to aid with all of these skills except self-as-context. Participants will be asked to use the app to practice these skills and to complete behavioral commitments linked to their values between sessions.
Behavioral: ACT groups and mobile app
See arm description.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Penn State Worry Questionnaire (PSWQ)
Time Frame: At posttreatment (6-10 weeks after baseline)
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
At posttreatment (6-10 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Penn State Worry Questionnaire (PSWQ)
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
Time Frame: At posttreatment (6-10 weeks after baseline)
The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
At posttreatment (6-10 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
Time Frame: At posttreatment (6-10 weeks after baseline)
The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity.
At posttreatment (6-10 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity in clinical samples.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
Time Frame: At posttreatment (6-10 weeks after baseline)
The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
At posttreatment (6-10 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
Time Frame: At posttreatment (6-10 weeks after baseline)
The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
At posttreatment (6-10 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
Time Frame: At posttreatment (6-10 weeks after baseline)
The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
At posttreatment (6-10 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
Time Frame: At posttreatment (6-10 weeks after baseline)
The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
At posttreatment (6-10 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
Time Frame: At posttreatment (6-10 weeks after baseline)
This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
At posttreatment (6-10 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
Time Frame: At posttreatment (6-10 weeks after baseline)
The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
At posttreatment (6-10 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
One month after the posttreatment survey is administered (10-14 weeks after baseline)
Credibility/Expectancy Questionnaire (CEQ)
Time Frame: At the end of the first group therapy session, 0-4 weeks after baseline
The CEQ is a 6-item measure of the credibility of a treatment approach and expectations of treatment outcomes. This measure has good reliability.
At the end of the first group therapy session, 0-4 weeks after baseline
Mobile app question: "How much are you....Feeling nervous, anxious, or on edge"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Worrying too much about different things"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Feeling down, depressed, or hopeless"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item was taken from the PHQ-9, a well-validated measure of depression. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Fighting your feelings"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item assesses momentary experiential avoidance. It is lacking full validation but has been used successfully in previous mobile app research.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Stuck in thoughts"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item assesses momentary cognitive fusion. It is lacking full validation but has been used successfully in previous mobile app research.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Running on autopilot"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item assesses momentary inattention. It is lacking full validation but has been used successfully in previous mobile app research.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Disconnected from values"
Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
This item assesses momentary values obstruction. It is lacking full validation but has been used successfully in previous mobile app research.
Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time Frame: At posttreatment (6-10 weeks after baseline)
The TEI-SF is a 9-item measure of treatment acceptability. In this study two items were omitted and others were revised to be appropriate for the present sample. This measure has good reliability and has been demonstrated to discriminate between different treatments.
At posttreatment (6-10 weeks after baseline)
Novel satisfaction items
Time Frame: At posttreatment (6-10 weeks after baseline)
13 novel items were developed assessing satisfaction with the intervention (both overall and for specific components).
At posttreatment (6-10 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Utah State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Twohig, PhD, Utah State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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